BCS II waiver approach [Dissolution / BCS / IVIVC]

posted by yuvaneshwari – India, 2019-01-23 06:09  – Posting: # 19801
Views: 455

Dear All,

Drug compound is BCS-II [dosage form is solution filled in capsule], and objective is to formulate with Q1 & Q2 sameness to that of Reference. Since API is in solution state filled in capsule, its solubility/bioavailability is improved tremendously.

In the above scenario, can we consider for BCS based waiver approach ?

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